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Trial record 87 of 1163 for:    MYCOPHENOLIC ACID

Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00434590
Recruitment Status : Terminated (The study has been stopped because of the lack of enrollment)
First Posted : February 13, 2007
Results First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
The study will evaluate kidney graft function in maintenance renal transplant patients.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Enteric coated mycophenolate sodium (Myfortic®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Study Completion Date : May 2008


Arm Intervention/treatment
Experimental: Full Dose Myfortic® and Reduced Dose Neoral®
The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
Drug: Enteric coated mycophenolate sodium (Myfortic®)
Other Name: Myfortic

Active Comparator: Standard Dose of Myfortic® and Standard Dose of CsA-ME
Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Drug: Enteric coated mycophenolate sodium (Myfortic®)
Other Name: Myfortic




Primary Outcome Measures :
  1. Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months [ Time Frame: 12 months ]
    The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.


Secondary Outcome Measures :
  1. Creatinine Clearance at 12 Months [ Time Frame: 12 months ]
  2. Serum Creatinine at 12 Months [ Time Frame: 12 months ]
  3. Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months [ Time Frame: 12 months ]
  4. Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months [ Time Frame: 12 months ]
  5. Chronic Rejection as Confirmed by Renal Biopsy at 12 Months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion criteria:

  • Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
  • Age > 18 yrs
  • Adequate and stable renal function
  • Informed consent.

Exclusion criteria:

  • Kidney transplant combined with other organs;
  • Significant proteinuria
  • Severe ongoing infections;
  • Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
  • Relapse of the end-stage renal disease on the transplanted kidney;
  • Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434590


Locations
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Italy
Novartis Investigative Site
Bologna, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Novartis

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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434590     History of Changes
Other Study ID Numbers: CERL080AIT09
First Posted: February 13, 2007    Key Record Dates
Results First Posted: April 7, 2011
Last Update Posted: April 7, 2011
Last Verified: March 2011

Keywords provided by Novartis:
Kidney Transplantation
Mycophenolic Acid
Immunosuppression
Cyclosporine

Additional relevant MeSH terms:
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Mycophenolic Acid
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents